Associate Director - Clinical Central Services & Innovation at Lilly

Indianapolis, Indiana, United States -

Full Time

Start Date

Immediate

Expiry Date

06 Feb, 26

Salary

169400.0

Posted On

08 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Trial Management, Regulatory Affairs, Project Management, Vendor Management, Operational Strategy, Community Health, Patient Services, Inspection Readiness, Continuous Improvement, Collaboration, Financial Acumen, Risk Management, Diversity Promotion, Customer Experience, Change Management, Communication Planning

Industry

Pharmaceutical Manufacturing

Description

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Organization Overview: The Clinical Central Services & Innovation (CCSI) organization is responsible for strategically planning and providing trial support services, clinical trial supplies and innovative capabilities to support the execution of clinical trials globally for all business units across all phases of development. This organization enables innovative and foundational solutions including but not limited to central pharmacy services, mobile healthcare, telemedicine, virtual trial orchestration, recruitment & retention, community screening, new site models, and digital devices. Our mission is to increase clinical research awareness and diversity while reducing the patient and investigator burden in order to speed medicines to those in need. This group is within the broader Clinical Capabilities organization and partners across functions within Clinical Design, Delivery and Analytics (CDDA) and Product Research and Development (PRD) to influence trial design and provide solutions to operationalize these trials and enable asset strategies across the portfolio. Responsibilities: The CCSI Associate Director is focused on the operations strategy and implementation for these capabilities. They will be responsible to drive the processes and oversee partnering with the clinical & design organizations to provide patient services like pharmacy and medical benefit coverage, direct-to-patient CT material delivery, and community-based research support. This role will also participate in maintenance and interpretation of decentralized trial regulations, clinical trial material regulations while working with global regulatory to align a consistent strategy across the portfolio. This role will also be responsible for vendor management and collaboration to drive implementation and coordinate efforts across the clinical capabilities’ teams. Capability Development and Delivery Serve as Operational Lead, develop business strategies, processes, and technology as it relates to clinical central services & innovation Partner with study teams, external partners, and vendors to develop innovative solutions for the delivery of trial activities and services at alternative site locations (e.g., patient home, community health center or other HCP location) Partner with Clinical, Regulatory, Product Delivery, Quality, Procurement, Finance, BU’s and other MDU functions to clearly understand the clinical trial requirements and patient needs to inform decisions around which capabilities best meet those requirements Provide expertise of global regulations governing decentralized clinical research at community based health and alternative site locations including the distribution of pharmaceutical products and other trial supplies and develop a strategic plan to comply with them Continuously maintain a state of inspection readiness. Participate and perform duties required for internal and external inspections as well as supporting institutions/investigators and alternative site locations in inspection readiness initiatives Drive benchmarking, continuous improvement, shared learning, and process expertise between teams Develop critical success factors for pilot programs/projects and monitor progress to ensure clear criteria exists to enable decision making Project Management Understand business and financial acumen while minimizing the risk, delays, and potential interruption of clinical trial programs Maintain operational alignment and prioritization for clinical services across functional and therapeutic areas Develop critical success factors for pilots/projects and monitor progress to ensure clear criteria exists to enable decision making Provide guidance and consulting into forecasting and managing expenses. Identify project implementation risks and raise issues appropriately. Lead progress reporting activities and metrics Manage Third Party Organization qualification process, selection, oversight Partnership Foster inclusion, innovation, and promote diversity Partner closely within and across teams to effectively plan, forecast, and manage the portfolio and project work Collaborate with vendors and other external partners to improve customer experience and monitor performance Lead organizational change, communication planning and training initiatives. Identify, monitor, and communicate global customer (internal and external) needs/requirements related to process and/or technology performance and improvements Basic Requirements: Bachelor’s degree and/or 3 to 5 years of industry or health care related experience (regulatory affairs and/or project management, clinical drug development or a healthcare related field) Knowledge of drug development process Strong networking, interpersonal and relationship skills with demonstrated ability to work in teams, across organizational boundaries and achieve results through others • Previous experience in a community health care setting Additional Preferences: Knowledge of emerging healthcare related services and capabilities for clinical research Knowledge of country regulatory guidelines/requirements for clinical research conduct License/Certificate Requirements: PharmD preferred Language Requirements: Must speak fluent English Additional Information/Requirements: Work outside of core hours may be required to support the portfolio across the globe May require travel domestically and international (less than 10%) Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $115,500 - $169,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

Responsibilities

The Associate Director will drive the operations strategy and oversee the implementation of clinical central services and innovative capabilities. They will partner with clinical and design organizations to provide patient services and ensure compliance with decentralized trial regulations.